The posting
Job Summary
Medline Industries has an immediate opening for a Director Complaint Process Operations & Investigations. This role will be based out of our Mundelein, IL office and will work a hybrid model. The Director, Complaint Process Operation and Investigations provides strategic and operational leadership for the complaint management process execution. This position is accountable for maintaining a compliant, effective, scalable, and standardized complaint quality system across products, division, expanding to geographic regions. The Director establishes strategy, governance, performance objectives, and operating model for complaint intake, investigation, escalation, reportability assessment, and closure. The role oversees operational performance, analytics, inspection readiness, process improvements, and the timely resolution of audit findings and process-related NCRs and CAPAs. This position leads and develops a team of quality professionals and collaborates with Quality, Regulatory Affairs, Medical Affairs, Clinical, Manufacturing, Distribution, Legal, Digital Technology, and business leadership.
Job Description
MAJOR RESPONSIBILITIES
Lead teams conducting complaints intake, reviews, investigations, coding, complaint/singular event risk analysis, escalations, reportability assessments, and closure activities.
Ensure complaint records and related quality outputs are complete, accurate, consistent, timely, and supported by appropriate documentation.
Ensure compliance with applicable regulatory requirements and internal quality system procedures.
Establish departmental objectives and operational priorities and use operational analytics and monitoring to identify emerging risks, negative performance trends, compliance concerns, and improvement opportunities.
Monitor operational KPIs and KQIs, quality metrics, capacity indicators, timeliness, investigation quality, and process effectiveness.
Ensure timely escalation of patient, product, regulatory, and business risks to Medical, Regulatory Affairs, Quality, and executive leadership.
Collaborate with cross-functional partners to resolve compliance issues and establish practical, sustainable, and compliant solutions.
Maintain inspection readiness and represent complaint operations during internal audits, external audits, regulatory inspections, and other compliance assessments.
Support complaint process improvements focused on compliance, investigation quality, customer experience, efficiency, simplification, and standardization.
Provide leadership to managers, supervisors, and professional staff.
Manage staffing, performance management, coaching, succession planning, and resource allocation.
Build technical expertise within the organization through mentoring and development activities.
Promote a culture of quality, compliance, accountability, and continuous improvement.
Translate divisional and functional strategies into operational surveillance plans.
Support development of post-market surveillance strategies for product portfolios and complaint process operation.
Partner with Regulatory Affairs, Medical Affairs, R&D, Manufacturing, Supply Chain, Legal, Commercial, Quality functions, regional teams, vendors, and other internal and external stakeholders.
Collaborate with product subject matter experts to ensure appropriate event assessment and escalation.
Contribute to quality system enhancements affecting Health Risk Analysis, CAPA, risk management, and field actions.
MINIMUM JOB REQUIREMENTS
Education
A bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline, or equivalent job-related knowledge.
Work Experience
The position requires at least 7 years of experience in medical device, pharmaceutical, biologic, or other regulated healthcare-product quality systems and demonstrated 4+ years of progressive people leadership experience leading complex professional teams. Relevant experience should include complaint handling, post-market surveillance, quality systems, regulatory reporting, and related regulatory requirements. The successful candidate must demonstrate deep working knowledge of applicable FDA, ISO, and international quality and post-market requirements; strong analytical, problem-solving, decision-making, and organizational planning capabilities; sound judgment in risk-based decision-making; ability to communicate effectively with executive management, regulatory authorities, technical teams, and stakeholders; and ability to manage multiple complex priorities and deliver results in a fast-paced, highly regulated environment.
Knowledge / Skills / Abilities
Demonstrated ability to lead through Senior Managers and Managers and drive organizational performance through others.
Knowledge of FDA, ISO 13485, ISO 14971, and global post-market surveillance requirements.
Strong understanding of complaint handling, CAPA, risk management, and field actions.
Ability to establish governance, priorities, performance metrics, and escalation pathways.
Excellent written, verbal, and presentation communication skills.
Ability to communicate effectively with executive management, regulatory authorities, technical teams, and stakeholders.
Ability to influence senior leaders and achieve cross-functional alignment.
Proficiency in Microsoft Office applications and data analysis tools.
Position requires travel up to 20% for business purposes (global).
PREFERRED JOB REQUIREMENTS
Education
An advanced degree in a relevant scientific, engineering, healthcare, regulatory, or business discipline and experience
Certification / Licensure
Certified Manager of Quality/Organization Excellence (ASQ CMQ/QE)
Work Experience
15 years of experience in leading globally distributed teams with complaint handling, investigations, regulatory reporting, corrections and removal, regulatory authority communications, and regulatory inspections or notified body audits is preferred. Additional beneficial experience includes responsibility across multiple product types or jurisdictions and working knowledge of risk management, design controls, manufacturing controls, validation, supplier controls, clinical or patient risk assessment, quality system records, and enterprise systems used to support investigation, traceability, and corrective action activities.
Knowledge / Skills / Abilities
Strong strategic thinking and ability to translate business and quality objectives into functional plans and execution.
Ability to lead regulatory inspections, notified body audits, and health authority interactions related to complaint handling, invesigatins and regualtory reporting.
Strong analytical, problem-solving, and decision-making skills with the ability to manage competing priorities and complex business risks.
Ability to develop talent, build organizational capability, and promote a culture of patient safety, accountability, and continuous improvementg.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$177,000.00 - $266,000.00 Annual
The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
